This multicenter pragmatic randomized controlled trial evaluates whether AI-assisted interpretation of low-dose CT (LDCT) improves lung cancer screening performance compared with standard reading. Eligible participants are randomized to AI-assisted or conventional interpretation. The study assesses diagnostic accuracy, efficiency, lung cancer incidence, mortality, recurrence, and smoking cessation outcomes. Results will inform the clinical utility and potential implementation of AI-assisted LDCT in routine screening practice.
Lung cancer is a leading cause of cancer-related mortality worldwide, and early detection is essential for improving survival. Low-dose computed tomography (LDCT) has been shown to reduce lung cancer mortality in high-risk populations, but image interpretation is time-consuming and may lead to overdiagnosis. Artificial intelligence (AI)-assisted diagnostic tools offer the potential to improve accuracy and efficiency in LDCT-based lung cancer screening, though challenges related to model adaptability, data heterogeneity, user trust, and regulatory compliance remain. This multicenter pragmatic randomized controlled trial evaluates the effectiveness of AI-assisted LDCT interpretation compared with standard interpretation. Eligible participants will be randomized to an AI-assisted arm or a standard-reading arm. Outcomes include diagnostic accuracy, efficiency, lung cancer incidence, lung cancer mortality, recurrence, and smoking cessation. The findings will provide evidence on the clinical utility of AI-assisted LDCT screening and support future implementation in routine practice and policy development.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
1,120
Participants undergo low-dose computed tomography (LDCT) lung cancer screening. The images are first interpreted by AI-assisted software, which highlights suspicious nodules. Radiologists then review the AI outputs and generate the final report.
Taipei Veterans General Hospital
Taipei, Taiwan, Taiwan
Lung Cancer Incidence
The proportion of newly diagnosed lung cancer cases identified within the specified follow-up period among all individuals who underwent LDCT screening.
Time frame: From baseline to 12 months, 36 months, and 60 months.
False Positive Rate
The proportion of LDCT screening results interpreted as positive that are subsequently confirmed as non-lung cancer based on further diagnostic imaging or pathological examination.
Time frame: Within 6 months following LDCT screening.
Lung Cancer Mortality
The proportion of participants who die from lung cancer within the specified follow-up period after undergoing LDCT screening.
Time frame: From baseline to 12 months, 36 months, and 60 months.
Lung Cancer Recurrence Rate
The proportion of patients previously diagnosed and treated for lung cancer who experience disease recurrence during the follow-up period.
Time frame: From baseline to 12 months, 36 months, and 60 months.
All-Cause Mortality
The proportion of deaths from any cause among all individuals who underwent LDCT screening during the study period.
Time frame: From baseline to 12 months, 36 months, and 60 months.
Time to Diagnosis
The time interval from LDCT screening to the date of confirmed lung cancer diagnosis, reported at the 12-month, 36-month, and 60-month follow-up time points.
Time frame: At the 12-month, 36-month, and 60-month follow-up assessments after LDCT screening.
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Time to Treatment Initiation
The time interval from the date of confirmed lung cancer diagnosis to the initiation of treatment, reported at the 12-month, 36-month, and 60-month follow-up time points.
Time frame: At the 12-month, 36-month, and 60-month follow-up assessments after lung cancer diagnosis.
Follow-up Completion Rate
The proportion of individuals who completed the scheduled follow-up examinations or clinical evaluations within the designated follow-up period after undergoing LDCT screening.
Time frame: Up to 12 months post-screening.
Smoking Cessation Rate
The proportion of individuals who successfully quit smoking within the follow-up period after LDCT screening
Time frame: Assessed at 3 months, 6 months, and 12 months after baseline screening.